Catheter assembly including monitoring capabilities

Abstract

A catheter assembly or other elongate tubular device for use in establishing vascular or other access within the body of a patient is disclosed. The catheter assembly is equipped with one or more sensors that enable monitoring of one or more physiological aspects of the patient or physical aspect of the catheter assembly itself when the catheter assembly is disposed within the patient. Such aspects include central venous pressure, body temperature, ECG heart signals, oxygen levels, ultrasound data, glucose, etc. The catheter assembly includes the ability to wirelessly transmit or otherwise forward data relating to the detected physiological parameters to another location, such as a patient electronic medical record, smartphone or other mobile device, nurse station, etc. Catheter assemblies configured to detect the frequency of catheter flushing, flushing quality, etc., are also disclosed.

What is claimed is: 
     
         1 . A method of making a catheter assembly, comprising:
 producing a catheter having a proximal end and a distal end, the proximal end configured to be positioned outside of a body of a patient when the catheter is in use, the distal end configured to be positioned inside of the body of the patient when the catheter is in use;   integrating a flush sensor in the proximal end of the catheter, the flush sensor configured to detect when the catheter assembly is being flushed with fluid, wherein the flush sensor is configured to be activated when a component is operably connected to the catheter assembly;   coupling a pressure sensor to the catheter, the pressure sensor configured to operate with the flush sensor to detect when the catheter assembly is being flushed with fluid; and   providing an auxiliary device separated from the catheter, the auxiliary device operably attached to the flush sensor and the pressure sensor, the auxiliary device configured to relay information from the flush sensor and the pressure sensor to a receipt location.   
     
     
         2 . The method according to  claim 1 , wherein the flush sensor includes a lever that is configured to be displaced when the component is operably connected to the catheter assembly. 
     
     
         3 . The method according to  claim 2 , wherein integrating the flush sensor comprises including the flush sensor in at least one of a luer connector and a needleless connector included with the catheter assembly. 
     
     
         4 . The method according to  claim 1 , wherein the auxiliary device comprises a wireless communication module configured to wirelessly transmit the information to the receipt location. 
     
     
         5 . The method according to  claim 4 , wherein the wireless communication module is configured to transmit data via at least one of Bluetooth, Wi-Fi, near-field communication, and radiofrequency signals. 
     
     
         6 . The method according to  claim 4 , further comprising incorporating the auxiliary device into a securement device, wherein the wireless communication module is included on a printed circuit board in the securement device. 
     
     
         7 . The method according to  claim 4 , wherein the auxiliary device is configured to be worn on the body or clothing of the patient. 
     
     
         8 . The method according to  claim 4 , wherein the auxiliary device comprises an armband. 
     
     
         9 . The method according to  claim 1 , wherein the auxiliary device includes a printed circuit board and a battery, the printed circuit board and the battery operably connected to at least one of the flush sensor and the pressure sensor via a connecting wire. 
     
     
         10 . The method according to  claim 1 , wherein the receipt location is selected from the group consisting of a smartphone, a storage device, a patient electronic medical record, a mobile device, a computer server, a laptop computer, a nurse station, and a printer. 
     
     
         11 . The method according to  claim 1 , further comprising incorporating at least one additional sensor into the catheter assembly, wherein the at least one additional sensor is selected from the group consisting of a temperature sensor, an ultrasound transducer, an electrical sensor configured to detect ECG signals, and a glucose sensor. 
     
     
         12 . The method according to  claim 1 , wherein the catheter includes a catheter hub at the proximal end, further comprising incorporating an oxygen sensor in the catheter hub. 
     
     
         13 . The method according to  claim 12 , further comprising incorporating a catheter physical aspect sensor into the catheter assembly. 
     
     
         14 . The method according to  claim 1 , further comprising including at least one light on the catheter assembly, the at least one light configured to operate in conjunction with one or both of the flush sensor and the pressure sensor. 
     
     
         15 . The method according to  claim 1 , further comprising incorporating a light array coupled to a timing circuit into the catheter assembly, the light array configured to visually indicate a status of the catheter. 
     
     
         16 . The method according to  claim 1 , further comprising including a temperature sensor in the catheter assembly, the pressure sensor and the temperature sensor configured to sense a respiratory rate, a heart rate, and a body temperature of the patient in order to determine whether a sepsis condition is present. 
     
     
         17 . The method according to  claim 16 , wherein the pressure sensor and the temperature sensor are disposed in a catheter hub positioned at the proximal end of the catheter. 
     
     
         18 . The method according to  claim 17 , wherein the temperature sensor extends in a longitudinal cavity in a wall of the catheter, and wherein the longitudinal cavity is filled with potting around the temperature sensor. 
     
     
         19 . The method according to  claim 1 , further comprising providing a pressure detection module detachably connectable to the catheter, wherein the pressure detection module comprises a pressure indicator in fluid communication with a lumen of the pressure detection module, the lumen of the pressure detection module in fluid communication with the lumen of the catheter. 
     
     
         20 . The method according to  claim 19 , wherein the pressure indicator includes an indicator piece that activates upon detection of a fluid pressure in excess of a predetermined pressure in the lumen of the catheter.